Home / 510(k) Clearances / K180209

510(k) K180209

Diazyme 1,5-AG Assay by Diazyme Laboratories, Inc. — Product Code NOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2018
Date Received
January 24, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, 1,5-Anhydroglucitol (15ag)
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes.

Other clearances by Diazyme Laboratories, Inc.

  • K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Li (December 19, 2025)
  • K243462 — Diazyme Colorimetric Lithium Assay (August 1, 2025)
  • K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (September 8, 2022)
  • K220001 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (August 4, 2022)
  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity (August 6, 2021)
  • K181438 — Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chai (June 26, 2018)
  • K180074 — Diazyme Lipoprotein (a) Assay (March 22, 2018)
  • K172992 — Diazyme EZ Vitamin D Assay (January 11, 2018)
  • K163418 — Diazyme DZ-Lite Total beta-hCG Test System (August 18, 2017)

Other clearances for product code NOZ

  • K031604 — GLYCOMARK (September 22, 2003)